| Our study management services include all elements of project development from the earliest steps to completion of a trial and beyond. Some of the core components of our study management services are the following: |
| |
| • |
Protocol development |
| • |
Investigator brochure write-up |
| • |
CRF design |
| • |
Site selection |
| • |
Regulatory approval process |
| • |
Site initiation, interim monitoring and close-out |
| • |
Audit support |
| • |
Data management |
| • |
Statistical services |
| • |
Report write-up to ICH requirements |
| • |
Regulatory submission |
|
| |
| In addition, we work with organised patient support groups in a variety of therapeutic areas, allowing us to quickly identify experienced investigators interested in clinical research. This is augmented by our online third party databases which are updated regularly and contain the latest professional contact information available on the medical community. |
